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MELBOURNE, Australia and INDIANAPOLIS, Dec. 30, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX, Telix, the Company) today announces that it has submitted its Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX250-CDx (Zircaix® 1 , 89 Zr- girentuximab) kidney cancer imaging 2 . TLX250-CDx is an investigational PET 3 drug product for the non-invasive diagnosis and characterization of clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer. If approved, TLX250-CDx will be the first and only targeted PET agent specifically for kidney cancer to be commercially available in the U.S., further building on Telix’s successful urology imaging franchise. The FDA is expected to advise the PDUFA 4 goal date following the 60-day administrative review of the application. Kevin Richardson, Chief Executive Officer, Precision Medicine at Telix, stated, “We are pleased to be progressing the BLA for TLX250-CDx, which has been granted Breakthrough designation, and may therefore be eligible for priority review. Telix continues to target a full U.S. commercial launch in 2025 addressing a major unmet medical need for patients with suspected ccRCC.” About TLX250-CDx TLX250-CDx (Zircaix® 1 ) is an investigational PET agent that is under development for the diagnosis and characterization of ccRCC. Telix’s pivotal Phase III ZIRCON trial (ClinicalTrials.gov ID: NCT03849118 ) evaluating TLX250-CDx in 300 patients, of whom 284 were evaluable, met all primary and secondary endpoints, including showing 86% sensitivity and 87% specificity and a 93% positive-predictive value for ccRCC across three independent radiology readers 5 . Telix believes this demonstrated the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing and characterizing ccRCC. Confidence intervals exceeded expectations amongst all three readers, showing evidence of high accuracy and consistency of interpretation. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialization of diagnostic and therapeutic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (Nasdaq: TLX). Telix’s lead imaging product, gallium-68 ( 68 Ga) gozetotide injection (also known as 68 Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA) 6 , by the Australian Therapeutic Goods Administration (TGA) 7 , and by Health Canada 8 . No other Telix product has received a marketing authorization in any jurisdiction. Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn . Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Investor Relations and Corporate Communications Email: kyahn.williamson@telixpharma.com This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board. Legal Notices You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our registration statement on Form 20-F filed with the SEC, or on our website. The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialisation of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. ©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®, Illuccix® and Zircaix® 1 names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. 1 Brand name subject to final regulatory approval. 2 Telix ASX disclosure 31 July 2024. The FDA requested additional data demonstrating adequate sterility assurance during dispensing of TLX250-CDx in the radiopharmacy production environment. 3 Positron emission tomography. 4 Prescription Drug User Fee Act. 5 Shuch et al. Lancet Oncol. 2024. Telix ASX disclosures 7 November 2022. 6 Telix ASX disclosure 20 December 2021. 7 Telix ASX disclosure 2 November 2021. 8 Telix ASX disclosure 14 October 2022.
By MICHAEL R. SISAK NEW YORK (AP) — Lawyers for Sean “Diddy” Combs tried for a third time Friday to persuade a judge to let him leave jail while he awaits his sex trafficking trial, but a decision won’t come until next week. Judge Arun Subramanian said at a hearing that he will release his decision on Combs’ latest request for bail after Combs’ lawyers and federal prosecutors file letters addressing outstanding issues. Those letters are due at noon on Monday, Subramanian said. Combs’ lawyers pitched having him await trial under around-the-clock surveillance either his mansion on an island near Miami Beach or — after the judge scoffed at that location — an apartment on Manhattan’s Upper East Side. Their plan essentially amounts to putting Combs on house arrest, with strict limits on who he has contact with. But prosecutors argue that Combs has routinely flouted jail rules and can’t be trusted not to interfere with witnesses or the judicial process. “The argument that he’s a lawless person who doesn’t follow instructions isn’t factually accurate,” Combs lawyer Anthony Ricco argued. “The idea that he’s an out-of-control individual who has to be detained isn’t factually accurate.” Combs, 55, has pleaded not guilty to charges that he coerced and abused women for years with help from a network of associates and employees while silencing victims through blackmail and violence, including kidnapping, arson and physical beatings. His trial is slated to begin May 5. The Bad Boy Records founder remains locked up at a Brooklyn federal jail, where he spent his Nov. 4 birthday. Two other judges previously concluded that Combs would be a danger to the community if he is released and an appeals court judge last month denied Combs’ immediate release while a three-judge panel of the 2nd U.S. Circuit Court of Appeals weighs his bail request. Friday’s hearing was the second time Combs was in court this week. On Tuesday, a judge blocked prosecutors from using as evidence papers that were seized from his cell during jail-wide sweep for contraband and weapons at the Metropolitan Detention Center in Brooklyn. Related Articles As he entered through a side door, Combs waved to relatives including his mother and several of his children in the courtroom gallery, tapping his hand to his heart and blowing kisses at them. He then hugged his lead attorney, Marc Agnifilo, before taking a seat at the defense table. He was not handcuffed or shackled and wore a beige jail uniform, occasionally pulling a pair of reading glasses from his pocket as he peered at papers in front of him. Prosecutors maintain that no bail conditions will mitigate the “risk of obstruction and dangerousness to others” of releasing Combs from jail. Prosecutors contend that while locked up the “I’ll Be Missing You” artist has orchestrated social media campaigns aimed at tainting the jury pool. They allege that he has also attempted to publicly leak materials he thinks would be helpful to his case and is contacting potential witnesses via third parties. “Simply put, the defendant cannot be trusted,” Assistant U.S. Attorney Christy Slavik argued. Combs’ lawyer Teny Geragos countered that, given the strict release conditions proposed, “it would be impossible for him not to follow rules.”The confidential briefing note is part of the tranche of documents made public in the annual release of State papers from the Irish National Archives. An Irish Department of Foreign Affairs official focusing on justice and security created the list in October 2002. The document starts by referencing a 1999 interview given by George Mitchell, the chairman of the Good Friday Agreement negotiations, in which he claimed the British and Irish governments, as well as Northern Ireland’s political parties, had leaked information to manipulate public opinion. However, he further accused the NIO of attempting to sabotage the process by leaking information on British Government policy to the media. Mr Mitchell, a former US senator, is said to have expressed alarm and anger over the frequency of leaks from the NIO – saying they were uniquely “designed to undermine the policy of the British Government of which they were a part”. The Irish civil servant notes Mr Mitchell himself was subjected to an attempted “smear” when he first arrived in Northern Ireland, as newspaper articles falsely claimed his chief of staff Martha Pope had had a liaison with Sinn Fein representative Gerry Kelly with ulterior motives. The Irish civil servant goes on to list several “leaks”, starting with the publication of a proposed deal in a newspaper while “intense negotiations” for the Downing Street Declaration were under way. Next, the Department lists two “high-profile and damaging leaks issued from the NIO”. A so-called “gameplan” document was leaked in February 1998, showing papers had been prepared weeks before the Drumcree march on July 6, 1997. In the preceding years, there had been standoffs and clashes as nationalists opposed the procession of an Orange parade down Garvaghy Road in Portadown. The gameplan document showed then secretary of state for Northern Ireland Mo Mowlam, who was publicly expressing a desire for a negotiated solution to the 1997 parade, advocated “finding the lowest common denominator for getting some Orange feet on the Garvaghy Road”. In 1997, a large number of security forces were deployed to the area to allow the march to proceed. The incident sparked heightened tension and a wave of rioting. The document further describes the release of a document submitted by the NIO’s director of communications to the secretary of state as a “second major leak”. It claims a publicity strategy was released to the DUP in the aftermath of the Good Friday Agreement and showed how the UK Government would support a yes vote in a referendum following any talks agreement. In addition, it is claimed unionists used leaked sections of the Patten report on policing to invalidate its findings ahead of its publication in 1999. The report recommended the replacement of the Royal Ulster Constabulary with the Police Service of Northern Ireland, the changing of symbols, and a 50-50 recruitment policy for Catholics and Protestants. At the time, UUP leader David Trimble said the recommendations would lead to a corruption of policing in Northern Ireland. Chris Patten, chairman of the independent commission on policing, said some of the assertions were a “total fabrication” and designed to “muddy the waters” to create a difficult political atmosphere. Elsewhere, the author notes it was leaked to the media there was serious disagreement between the governments of the UK and Ireland on the composition of that commission – with not a single name submitted by the Irish side being accepted by the other. The author notes this incident, still under the heading “NIO leaks”, was believed by British officials to have emanated from the Irish side. The report turns to leaks of other origin, claiming “disgruntled Special Branch officers in Northern Ireland” were blamed by the British Government for a series of releases about the IRA which were designed to damage Sinn Fein in the 2001 general election in Northern Ireland. One senior Whitehall source was quoted in the Guardian as complaining that Special Branch was “leaking like a sieve” after details of an IRA intelligence database containing the names of leading Tories – described at the time as a “hit list” – was passed to the BBC in April 2002. The briefing note adds: “This was followed days later by a leak to The Sunday Telegraph which alleged that senior IRA commanders bought Russian special forces rifles in Moscow last year. “The newspaper said it was passed details by military intelligence in London.” The briefing note adds that other Special Branch leaks were associated with the Castlereagh break-in. The final incident in the document notes the Police Ombudsman’s Report on the Omagh bombing was also leaked to the press in December 2001. Then Northern Ireland secretary John Reid said at the time: “Leaks are never helpful and usually malicious – I will not be commenting on this report until I have seen the final version.” The reason for creating the list of leaks, which the Irish National Archives holds in a folder alongside briefing notes for ministers ahead of meetings with officials from the UK Government and NIO, is not outlined in the document itself. – This document is based on material in 2024/130/6.
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